Trial | NCT04125082  Report issue

Title

A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections
A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    29
The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data
Study Started
Feb 27
2019
Primary Completion
Mar 15
2020
Anticipated
Study Completion
Mar 15
2020
Anticipated
Last Update
Jan 30
2020

Drug Afrezza Inhalant Product

Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks.

Type 2 Diabetics Other

Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks. Participants will attend study visits at Day 0, Weeks 1, 2, 3, 4, 8, 12 and 16, where insulin titration may be performed based on CGM readings. Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments. Participants will wear CMG throughout the study. At final study visit, CGM system will be collected. A1c, FEV1 and Quality of Life Questionnaires will be collected. Pregnancy test will be collected for all females of child-bearing potential. Participants will be transitioned back to Multiple Daily Injections plus basal or may choose to continue on commercial Afrezza® inhaled insulin plus basal

Criteria 

Inclusion Criteria:

Age 18 years or older
Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections
Screening A1c 7.5 % - 11.5% inclusive
Willing and able to wear CGM system during the study
Willing to use only inhaled insulin (Afrezza®) at meals and for correction
Able to understand, speak, read and write English
Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy

Exclusion Criteria:

Diagnosed with COPD
Is an active smoker , or has smoked in the past 6 months
Diagnosed with asthma
Pregnancy, breast-feeding or planning to become pregnant during study period
Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study
Use of oral or injected corticosteroid within 6 weeks of study enrollment
Enrollment in another investigational trial at the time of screening
No Results Posted